Windstone Medical Recalls Universal Surgery Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 99 Universal Pack surgery kits because the included Medtronic gloves may have splits or holes that compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (compromised sterility in surgical kits) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 99 Universal Pack kits (Kit number AMS2036) used for general surgery in hospital operating rooms. The recall is due to a defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES (Part # 13140) included in the custom kits. The gloves may contain splits or holes that compromise sterility.
The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The recall involves specific lot numbers and expiration dates, including 63911 (6/1/2014), 61913 (8/10/2014), 71796 (9/3/2014), 68840 (9/12/2014), 58646 (12/17/2014), 74391 (6/18/2016), and 78100 (6/30/2016).
Healthcare facilities should check their inventory for these specific lot numbers and expiration dates. If the affected kits are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Universal Pack, Kit number AMS2036 convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 99
Distribution
Part of a larger recall action
This product is one of 150 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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